Medical devices, 2025
Shortlist up to four to read them side by side.
2,908 medical device recalls FDA’s Enforcement Report published in 2025, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
2,908of 2,908 medical device recallsshown with your filters
The list
- Medical device recall Model Number U125, VALITUDE CRT-P EL Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall Model Number U128, VALITUDE CRT-P EL MRI Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall Model Number U225 VISIONIST CRT-P EL Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall Model Number U226, VISIONIST CRT-P EL Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall Model Number U228, VISIONIST CRT-P EL MRI Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall Flow Re-Direction Endoluminal Devices: FRED 27 Flow diverter may have a manufacturing issue related to the tantalum length and/or tantalum attachment pattern, which may lead the device to be incompletely… Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Florida, Nebraska, New York, South Carolina, South Dakota and Texas named
- Medical device recall TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D) Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D) Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F) Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J) Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F) Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall Neuroguard IEP 3 Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter that may not open or may not fully open… Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, Connecticut, Delaware, Florida, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Utah and Wisconsin named
- Medical device recall The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field,… The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying… Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall FERNO POWER X2 POWERED AMBULANCE COT The fastening post hardware could loosen allowing the fastening post to detach from the cot Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Illinois, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia, Wisconsin and West Virginia named
- Medical device recall Cyclopen Microinterventional Cyclodialysis System Potential for compromised integrity of the sterile packaging. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Maryland, Michigan, Minnesota, Missouri, Mississippi, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall C-Rex UNO Microinterventional Goniotomy Instrument Potential for compromised integrity of the sterile packaging. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Maryland, Michigan, Minnesota, Missouri, Mississippi, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Medline Adult Anesthesia Set Specific items and lots of Medline Kits may contain Clearlink IV Sets which Baxter recalled due to customer reports of leaking. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Missouri named
- Medical device recall TENACIO Pump with InhibiZone The potential for devices to experience inflation and/or deflation performance issues or difficulties. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TENACIO Pump without InhibiZone The potential for devices to experience inflation and/or deflation performance issues or difficulties. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CX Preconnect with TENACIO Pump without InhibiZone The potential for devices to experience inflation and/or deflation performance issues or difficulties. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LGX Preconnect with TENACIO Pump without InhibiZone The potential for devices to experience inflation and/or deflation performance issues or difficulties. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CX Preconnect with TENACIO Pump with InhibiZone The potential for devices to experience inflation and/or deflation performance issues or difficulties. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CXR Preconnect with TENACIO Pump with InhibiZone The potential for devices to experience inflation and/or deflation performance issues or difficulties. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LGX Preconnect with TENACIO Pump with InhibiZone The potential for devices to experience inflation and/or deflation performance issues or difficulties. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: ARVIS Product Name: ARVIS” Shoulder Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Indiana, Kentucky, Michigan, Minnesota, Missouri, Ohio, Pennsylvania, Rhode Island, Washington and Wisconsin named
- Medical device recall XERF EFFECTOR 60 Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse events for patients. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Illinois, Massachusetts, New Jersey, New York, Pennsylvania, Texas and Utah named
- Medical device recall ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of… The devices were shipped unsterilized. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part ID/Description: 18593… Potential packaging issue that could compromise the sterile barrier. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 22, 2025ClassClass IIStatusOngoingWhereMichigan and Texas
- Medical device recall BioPro Endo Head (Metal uni-polar, 38-55) Product Number/Description 10179 ENDO MD 38 10180 ENDO MD 41 10181… Potential packaging issue that could compromise the sterile barrier. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 22, 2025ClassClass IIStatusOngoingWhereMichigan and Texas
- Medical device recall BioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131 BIPOLAR HEAD 39MM 18132 BIPOLAR HEAD… Potential packaging issue that could compromise the sterile barrier. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 22, 2025ClassClass IIStatusOngoingWhereMichigan and Texas
- Medical device recall BioPro Femoral Head (Ceramic heads 28-30) Product ID/Description 19023 HEAD FEMORAL CERAMIC 28MM -3 19024… Potential packaging issue that could compromise the sterile barrier. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 22, 2025ClassClass IIStatusOngoingWhereMichigan and Texas
- Medical device recall BioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERAMIC SH 38 13012 ENDO MODULAR CERAMIC… Potential packaging issue that could compromise the sterile barrier. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 22, 2025ClassClass IIStatusOngoingWhereMichigan and Texas
- Medical device recall BioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT 14090 HEAD FEMORAL 28 MD LT 14091 HEAD… Potential packaging issue that could compromise the sterile barrier. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 22, 2025ClassClass IIStatusOngoingWhereMichigan and Texas
- Medical device recall LOGIQ P10 series with software version R4.5.7 The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7. The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7. The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723 When unintentionally disconnected from power source, humidifier device (used to deliver high flow warmed and humidified respiratory gases) may sound audible… Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall DuoDERM” Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to… Wound dressing may have foreign matter on the product. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Cardiac Workstation 5000 Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Iowa, Tennessee, Texas and Virginia named
- Medical device recall Cardiac Workstation 7000 Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Iowa, Tennessee, Texas and Virginia named
- Medical device recall Brand Name: Branding is not applied to this product Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk… Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Brand Name: Branding is not applied to this product Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk… Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Brand Name: Branding is not applied to this product Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk… Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Basic Biopsy Tray Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Iowa, Illinois, Minnesota, South Dakota and Washington named
- Medical device recall Basic Biopsy Tray Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Iowa, Illinois, Minnesota, South Dakota and Washington named
- Medical device recall Medical convenience kits Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Iowa, Illinois, Minnesota, South Dakota and Washington named
- Medical device recall Medical convenience kits Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Iowa, Illinois, Minnesota, South Dakota and Washington named
- Medical device recall Medical convenience kits Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Iowa, Illinois, Minnesota, South Dakota and Washington named
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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